Original article
Intervention
Effect of Lactobacillus sakei supplementation in children with atopic eczema–dermatitis syndrome

https://doi.org/10.1016/j.anai.2010.01.020Get rights and content

Background

Probiotics have been suggested to be useful in children with atopic eczema–dermatitis syndrome (AEDS).

Objective

To assess the clinical effect of Lactobacillus sakei supplementation in children with AEDS.

Methods

In a double-blind, placebo-controlled trial, children aged 2 to 10 years with AEDS with a minimum SCORing of Atopic Dermatitis (SCORAD) score of 25 were randomized to receive either daily L sakei KCTC 10755BP or daily placebo supplementation for 12 weeks. Changes in SCORAD scores and serum chemokine levels from baseline were evaluated.

Results

Eighty-eight children were enrolled, and 45 were allocated to probiotic treatment. Seventy-five children completed the study, with 4 dropouts in the probiotic group and 9 in the placebo group. At week 12, SCORAD total scores adjusted by pretreatment values were lower after probiotic treatment than after placebo treatment (P = .01). There was a 31% (13.1-point) improvement in mean disease activity with probiotic use compared with a 13% (5.2-point) improvement with placebo use (P = .008). Significant differences in favor of probiotic treatment were also observed in proportions of patients achieving improvement of at least 30% and 50%. Compared with placebo, probiotic administration was associated with lower pretreatment-adjusted serum levels of CCL17 and CCL27 (P =.03 for both), which were significantly correlated with SCORAD total score (r = 0.59 and 0.63, respectively; P < .001).

Conclusions

Supplementation of L sakei in children with AEDS was associated with a substantial clinical improvement and a significant decrease in chemokine levels, reflecting the severity of AEDS.

Introduction

Atopic eczema–dermatitis syndrome (AEDS) is a common chronic inflammatory skin disease that can be complicated by recurrent skin infections.1 The increase in prevalence and the clinical challenge of management have highlighted the need to develop new therapeutic approaches to control AEDS. Based on the knowledge of potential benefits from modification of the gastrointestinal flora, obvious interests in the preventive and therapeutic role of probiotics in AEDS have been aroused. In particular, results of population-based studies2, 3 suggest that childhood enteric infection and increased exposure to bacteria are protective against allergies, facilitating the clinical trial of probiotics for the management of AEDS.

Because rapid colonization occurs in the first year of life until a stable gut microflora is established,4 most previous studies examined the effect of early probiotic supplementation. Perinatal administration of probiotics to at-risk infants halved the subsequent occurrence of AEDS in IgE-independent mechanisms.5, 6 Probiotics were also shown to reduce the severity of AEDS when administered to infants with early-onset AEDS,7, 8, 9 although other clinical trials10, 11 have not shown AEDS-related benefits of probiotic supplementation during infancy. In contrast, only a few clinical trials have evaluated the effectiveness of probiotics on older children with established AEDS. In these trials,12, 13, 14 the administration of probiotics to children 1 year and older seems able to improve the manifestations of AEDS.

The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against Staphylococcus aureus growth among Lactobacillus species in a preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide more objective evidence for the beneficial role of this probiotic.

Section snippets

Patients and Study Design

Children aged 2 to 10 years were recruited between January 1, 2007, and August 31, 2008, to study the effects of the probiotic on AEDS symptoms at the Department of Pediatrics, Chungbuk National University Hospital. AEDS was defined as a pruritic chronic or chronically relapsing noninfectious dermatitis with typical features and distribution as suggested by Hanifin.15 The inclusion criteria were AEDS present for at least 6 months, a SCORing of Atopic Dermatitis (SCORAD) total score greater than

Study Population

Of the 107 individuals who were screened, 88 met the entry criteria and were randomized to treatment, 45 to the probiotic group and 43 to the placebo group (Fig. 1). Of these patients, 13 were withdrawn because of refusal to ingest the powder, nonattendance at scheduled visits, poor compliance, and ingestion of other probiotic agents. No significant differences in dropout rates were observed between the groups (P = .11). Compliance was good, with 91% of doses administered and no difference

Discussion

Current evidence is more convincing for the efficacy of probiotics in the prevention rather than the treatment of AEDS.20 However, despite the mixed results in clinical trials7, 8, 9, 10, 11 evaluating the therapeutic potential of probiotics during infancy or childhood including infancy, data in clinical trials12, 13, 14 for the treatment of established AEDS seem to be favorable in children older than 1 year. We also examined the beneficial role of probiotics in older children aged 2 to 10

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      The doses, duration, and concentrations of probiotics were very wide. Some of the most representative studies are summarized in Table VIII.82,120,122 The analysis found little or no difference for a reduction in SCORing Atopic Dermatitis (SCORAD), no difference for patient-reported outcomes, and no evidence for a difference in quality of life.

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    Disclosures: Authors have nothing to disclose.

    Funding Sources: This research was supported by the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology (2010-0001271).

    Trial Registration:clinicaltrials.gov Identifier: NCT00893230.

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